The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Mervyn Singer, Clifford S Deutschman, Christopher Warren Seymour...
https://pubmed.ncbi.nlm.nih.gov/26903338Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07372131
Appropriate Management of Bacteriemic Febrile Neutropenia in High-Risk Hematological Patients: Relationship Between Antibiotic Duration, Outcomes, and Resistance Profile
Led by Humanitas University · Updated on 2026-01-28
172
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
H
Humanitas University
Lead Sponsor
M
Ministry of education, university and research, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating if a personalized duration of antibiotic therapy, based on clinical stability, works as well as a standard 10-day antibiotic course in hospitalized patients with blood cancers like leukemia or lymphoma who develop febrile neutropenia and Gram-negative bloodstream infections. The study aims to see if personalized treatment increases the number of days without antibiotics within 28 days while staying safe, and how treatment length affects gut bacteria recovery. Participants are randomly assigned to one of two groups after confirming their Gram-negative infection. One group stops antibiotics after they have stable vital signs and no fever for 72 hours. The other group receives at least 10 days of antibiotics as usual, based on doctor decisions and current guidelines. A microbiological sub-study collects blood, stool, and rectal swab samples at fever onset, end of treatment, and day 28 to study gut and blood bacteria and resistance genes. During the 28-day study period, participants are closely monitored for new fevers, infection recurrence, and survival. Those in the sub-study provide biological samples for advanced genetic testing to track bacterial changes and antibiotic resistance. The main measurement is days free from Gram-negative antibiotics within 28 days. Safety and infection outcomes are regularly assessed to understand the effects of shorter versus standard antibiotic durations.
CONDITIONS
Brief Title
Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with a hematologic malignancy eligible for chemotherapy, bone marrow transplant, or CAR-T therapy
- Febrile neutropenia defined as fever ≥38.3°C once or ≥38.0°C sustained for 1 hour, with neutrophil count <1000 cells/microL
- Expected neutropenia duration of 7 days or more
- Confirmed bloodstream infection with positive blood culture for Gram-negative bacteria
You will not qualify if you...
- Diagnosis of pneumonia
- Diagnosis of intra-abdominal infection such as neutropenic enterocolitis or biliary tract infection
- Persistently positive blood cultures at time of randomization
- Any condition that puts patient safety at risk as judged by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Varies by clinical stability; minimum suggested duration of 10 days for standard care
Participants receive antibiotic therapy for Gram-negative bacteraemia. Those in the Personalized Duration arm will have antibiotics discontinued after achieving 72 consecutive hours of clinical stability. Those in the Standard of Care arm will follow local clinical practice with a suggested minimum of 10 days of antibiotic therapy.
Approximately 1 to 2 visits during antibiotic therapy
Follow-up
Duration - Up to 28 days from treatment start
Participants are monitored clinically until 28 days after starting treatment to assess outcomes including fever episodes, bloodstream infection relapse, and antibiotic-related adverse events.
Clinical monitoring visits until Day 28
Trial Site Locations
Total: 1 location
1
Microbiology and Virology - IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Actively Recruiting
Loading map...
Research Team
V
Valeria Cento, MD, PhD
M
Michele Bartoletti, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Microbiota as Predictor of Mortality in Allogeneic Hematopoietic-Cell Transplantation.
Jonathan U Peled, Antonio L C Gomes, Sean M Devlin...
https://pubmed.ncbi.nlm.nih.gov/32101664Reconstitution of the gut microbiota of antibiotic-treated patients by autologous fecal microbiota transplant.
Ying Taur, Katharine Coyte, Jonas Schluter...
https://pubmed.ncbi.nlm.nih.gov/30257956Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia: A Randomized Clinical Trial.
Elodie von Dach, Werner C Albrich, Anne-Sophie Brunel...
https://pubmed.ncbi.nlm.nih.gov/32484534Treatment duration for Escherichia coli bloodstream infection and outcomes: retrospective single-centre study.
M Giannella, R Pascale, A Toschi...
https://pubmed.ncbi.nlm.nih.gov/29371138Seven Versus 14 Days of Antibiotic Therapy for Uncomplicated Gram-negative Bacteremia: A Noninferiority Randomized Controlled Trial.
Dafna Yahav, Erica Franceschini, Fidi Koppel...
https://pubmed.ncbi.nlm.nih.gov/30535100Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America.
Leonard A Mermel, Michael Allon, Emilio Bouza...
https://pubmed.ncbi.nlm.nih.gov/19489710Early discontinuation of antibiotics for febrile neutropenia versus continuation until neutropenia resolution in people with cancer.
Anat Stern, Elena Carrara, Roni Bitterman...
https://pubmed.ncbi.nlm.nih.gov/30605229Discontinuation of antimicrobial therapy in adult neutropenic haematology patients: A prospective cohort.
Zoé Van de Wyngaert, Céline Berthon, Houria Debarri...
https://pubmed.ncbi.nlm.nih.gov/30831232Optimisation of empirical antimicrobial therapy in patients with haematological malignancies and febrile neutropenia (How Long study): an open-label, randomised, controlled phase 4 trial.
Manuela Aguilar-Guisado, Ildefonso Espigado, Almudena Martín-Peña...
https://pubmed.ncbi.nlm.nih.gov/29153975